The Niche

Cracking down on stem cell companies

Cross-posted from In the Field for Elie Dolgin

The International Society for Stem Cell Research (ISSCR) has convened a new committee tasked with weeding out companies that offer unapproved stem cell ‘therapies’, the ISSCR’s new president Irving Weissman announced today at the World Stem Cell Summit in Baltimore, Maryland.

See also an analysis of why unproven, risky stem-cell procedures elude legal restrictions in countries like China, India, Thailand, and the United States.

Last month, Weissman, who also directs the Stanford Institute for Stem Cell Biology and Regenerative Medicine in Palo Alto, California, wrote an opinion article in Cell Stem Cell calling for stem cell purveyors to be judged on three criteria. First, the company should be able to cite peer-reviewed papers from third party investigators showing that the therapy is possible. Second, there should be institutional review board oversight of the treatment. Third, the US Food and Drug Administration or an equivalent agency should give the final green light. “That’s the minimum beginning,” he said at the meeting.

Weissman revealed that he had convened an 18-member panel of lawyers, FDA regulators, medical ethicists, and stem cell scientists last week to look into the feasibility of establishing an online registry of wayward companies. His idea is for the ISSCR supervisory body to request documentation of the three requirements from all known global stem cell providers. Companies that don’t comply would get blacklisted.

Weissman expects the committee to issue a preliminary report in December, with final guidelines published next March.

Image of Weissman by Kris Novak

See an interview Irving Weissman: culturing the unorthodox

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